Coagulation factors, in the form of more or less pure concentrates, represent an important material for the preparation of parenteral compositions for clinical use and laboratory diagnosis of coagulation disorders and for use as markers of certain disease. The preparations are used by patients with a hereditary or acquired deficiency in blood coagulation, by acute hemorrhagy, pre-surgery prophylaxis of bleeding, damage of liver parenchyme, or by vitamin K deficiency; etc.
The established method for preparation of these coagulation factor concentrates, using sorbents based on a polysaccharide matrix, e.g., diethylaminoethyl- or DEAE-, has some disadvantages. The polysaccharide matrix is highly susceptible to microbial contamination, which causes physical and chemical changes in the sorbent. Polysaccharide sorbent particles are less resistant to change in environmental conditions, e.g., temperature, pressure, salt concentration, etc., the result of which is a change in the sorbent's volume with all the undesirable resulting consequences. Because of the different matrix of the hydroxyalkyl methacrylate sorbent, on the one hand, and polysaccharide, on the other hand, the behavior of the coagulation factors, i.e., factor II, VII, IX and X, during chromatographic separation on these materials is different to a certain degree.